FDA 510(k) Application Details - K112421

Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered

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510(K) Number K112421
Device Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant EMG TECHNOLOGY CO., LTD.
NO.58, 35 RD, TAICHUNG
INDUSTRIAL PARK, SHITUEN CHIU
TAICHUNG 40768 TW
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Contact PAUL CHO
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Regulation Number 878.4780

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Classification Product Code JCX
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Date Received 08/23/2011
Decision Date 09/01/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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